Senior QC Associate
RK3543
12 Months
Dublin


We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.


The Senior QC Associate will be responsible for one or more of the following activities in QC including sample and data management and equipment maintenance.

• Contributes to team by ensuring the quality of the tasks/services provided by self
• Contributes to the completion of milestones associated with specific projects or activities within team
• This role will support QC and manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.


Duties:

• Execute sample management activities across the site – sample distribution, LIMS logging, shipment receipt
• Perform Stability Program related activities such as pulling stability samples, study initiations.
• Create/own and approve protocols, sample plans., SOPs, training manuals.
• Perform SAP, LIMS and CIMS functions/ transactions within the sample management remit
• Out of hours responder for sample management equipment (fridges /freezers / incubators)
• Responsible for their own training and safety compliance.
• Sample shipments and temperature monitoring activities.
• LIMS data coordination of commercial and import batches.
• Management and maintenance of the Site Inventory of Reference Standards, Assay Controls, Training and Verification samples.
• QC Representative for NPI activities and routine Product meetings as required.
• Liaise with site Planning, Manufacturing and Inspection regarding manufacturing schedule and required QC testing.
• Liaise with Stability Product Representatives and Product Quality Leads as required.
• Perform routine sample management tasks as per procedures.
• With a high degree of technical flexibility, work across diverse areas within QC
• Plan and perform multiple, complex routine/ non-routine tasks with efficiency and accuracy.
• Report, evaluate, back-up/archive, trend and approve data.
• Troubleshoot, solve problems and communicate with stakeholders.
• Initiate and/or implement changes in controlled documents and equipment.
• Participate in audits, initiatives, and projects that may be departmental or organizational in scope

Education and Experience :

• Bachelor’s degree in a Science related field is required.
• 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry
• 2 + years of specific sample management/ stability programme experience is desirable.
• Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.


If interested in this posting please feel free to contact Rachel Kent at Life Science Recruitment for further information.